Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether Botox injection in anterior belly of digastric muscle in BSSO for mandibular advancement surgery could reduce the tendency of postoperative relapse.

Research question:

(P) In patient has skeletal class II mandibular retrognathism, (I) will Botox injection in anterior belly of digastric. (O) Affect the relapse of the mandible after mandibular advancement orthognathic surgery?

Participants will be undergo Botox injection in anterior belly of digastric and bilateral sagittal split surgery

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• Patients need bilateral sagittal split osteotomy for correction of skeletal class II malocclusion (mandibular retrognathism).

• Age of the patient above 18 years.

• All patients are free from any systemic disease that may affect normal bone healing.

Exclusion Criteria:

• Patient with history of facial bone trauma, cleft lip or palate.

• Intra-bony lesions or infections that may interfere with surgery.

• Previous orthognathic surgeries.

• Patients with relative contraindications to (BTX) injection such as pregnancy, lactation, neuromuscular diseases (e.g., myasthenia gravis), motor neuron disease, allergy to any of the components of (BTX).